Drape attachment to sterile adapters for use in a robotic surgical system

ABSTRACT

Generally, a sterile adapter for use in robotic surgery may include a frame configured to be interposed between a tool driver and a surgical tool, a plate assembly coupled to the frame, and at least one rotatable coupler supported by the plate assembly and configured to communicate torque from an output drive of the tool driver to an input drive of the surgical tool.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority to U.S. Patent Application Ser. No.62/436,957, filed on Dec. 20, 2016, and to U.S. Patent Application Ser.No. 62/436,965, filed on Dec. 20, 2016, and to U.S. Patent ApplicationSer. No. 62/436,974, filed on Dec. 20, 2016, and to U.S. PatentApplication Ser. No. 62/436,981, filed on Dec. 20, 2016, each of whichis hereby incorporated by reference in its entirety.

TECHNICAL FIELD

This invention relates generally to robotic surgical systems, and morespecifically to new and useful sterile adapters for creating a sterilebarrier around portions of a robotic surgical system.

BACKGROUND

Minimally-invasive surgery (MIS), such as laparoscopic surgery, involvestechniques intended to reduce tissue damage during a surgical procedure.For instance, laparoscopic procedures typically involve creating anumber of small incisions in the patient (e.g., in the abdomen), andintroducing one or more tools and at least one camera through theincisions into the patient. The surgical procedures are then performedby using the introduced tools, with the visualization aid provided bythe camera. Generally, MIS provides multiple benefits, such as reducedpatient scarring, less patient pain, shorter patient recovery periods,and lower medical treatment costs associated with patient recovery.

MIS may be performed with non-robotic or robotic systems. Conventionalrobotic systems, which may include robotic arms for manipulating toolsbased on commands from an operator, may provide many benefits of MISwhile reducing demands on the surgeon. Control of such robotic systemsmay require control inputs from a user (e.g., surgeon or other operator)via one or more user interface devices that translate manipulations orcommands from the user into control of the robotic system. For example,in response to user commands, a tool driver having one or more motorsmay actuate one or more degrees of freedom of a surgical tool when thesurgical tool is positioned at the surgical site in the patient.

Similar to traditional surgical procedures, it is important to maintaina sterile environment in the surgical field during robotic MIS. However,various components (e.g., motors, encoders, sensors, etc.) of the tooldriver and other aspects of the robotic surgical system cannotpractically be sterilized using conventional sterilization methods suchas heat. One solution to maintain sterility is to provide a sterilebarrier between the tool driver (and other system components that mayappear in the surgical field such as robotic arms, etc.) and thesurgical tool, thereby providing a “non-sterile” side for the tooldriver and a “sterile” side for the surgical tool. However, the sterilebarrier must not interfere with how the tool driver actuates thesurgical tool. Furthermore, as a tool driver may need to actuatedifferent surgical tools throughout a surgical procedure, the sterilebarrier may facilitate simple and efficient exchange or swapping ofsurgical tools on a tool driver, without compromising the sterilebarrier. Thus, it is desirable to have new and improved sterile adaptersin a sterile barrier for use in robotic surgery.

SUMMARY

Generally, a sterile adapter for use in a robotic surgical system mayinclude a frame configured to be interposed between a tool driver and asurgical tool, a plate assembly coupled to the frame, and at least onerotatable coupler supported by the plate assembly and configured tocommunicate torque from an output drive of the tool driver to an inputdrive of the surgical tool. In one variation, the plate assembly mayinclude a plurality of tool engagement features, where each toolengagement feature is mateable with a corresponding adapter engagementfeature on the surgical tool. The frame may be configured to couple tothe surgical tool when each tool engagement feature is mated with itscorresponding adapter engagement feature on the surgical tool. The toolengagement features on the sterile adapter may, for example, include aplurality of recesses and/or protrusions that are arranged in a linearseries of progressively increasing length along a tool insertiondirection.

In another aspect, the plate assembly in the sterile adapter may includeat least one abutment. The surgical tool may be configured, for example,to deliver a force directed along a longitudinal axis of the surgicaltool, and the abutment of the sterile adapter may be configured totransmit the force to the tool driver. For example, the abutment mayinclude a rib or other projection on a tool driver-facing surface of thesterile adapter, where the rib is configured to extend into a surface ofthe tool driver in order to transfer a force received by the plateassembly and rib to the tool driver.

In another aspect, the plate assembly may include a first face and asecond face opposite the first face, where the first face may include atleast one spring that is configured to urge the second face toward thesurgical tool. The spring may include, for example, a beam spring, acoil or leaf spring, or other compliant material suitable for urging thesecond face of the plate assembly toward the surgical tool.

Generally, in other variations, a sterile adapter for use in a roboticsurgical system may include a frame, a plate assembly coupled to theframe, and at least one rotatable coupler supported by the plateassembly and configured to communicate torque from an output drive of atool driver to an input drive of a surgical tool. The coupler may, forexample, include a first face having a first engagement featureconfigured to engage the output drive of the tool driver, and a secondface having a second engagement feature configured to engage the inputdrive of the surgical tool. The first and second engagement features mayhave different shapes. For example, one or both of the engagementfeatures may include a recess for engaging a projection on the outputdrive or input drive (and/or a projection for engaging a channel on theoutput drive or input drive). In another example, the first engagementfeature may include an arcuate feature (e.g., recess or projection) andthe second engagement feature may include a central feature (e.g. recessor projection) substantially centered on an axis of rotation of therotatable coupler. The first and second engagement features may extendin opposite axial directions in the coupler (e.g., both may be recessesextending into the body of the coupler, or both may be projectionsextending outwards from the body of the coupler). Furthermore, the firstface of the rotatable coupler may include a first set of pin holes forengaging with the output drive of the tool driver, and the second facemay include a second set of pin holes for engaging with the input driveof the surgical tool.

The frame of the sterile adapter may, in other variations, include abody configured to be interposed between a tool driver and a portion ofa surgical tool, and a mount projecting from the body for receiving theportion of the surgical tool. The body of the frame may include a firstend and a second end opposite the first end, where in some variations anengagement feature may be disposed on the first end of the body forcoupling to a first portion of the surgical tool overhanging the bodyand/or a platform mount may project (e.g., perpendicularly) from thesecond end of the body for receiving a second portion of the surgicaltool. A movable locking member may be included in the sterile adapterand be selectively operable between an engaged position in which thelocking member secures a coupling of the frame to the tool driver and adisengaged position in which the locking member facilitates a decouplingof the frame from the tool driver. For example, in some variations, thedisengaged position may be blocked when the portion of the surgical toolis received in the mount, thereby substantially preventing the sterileadapter from decoupling from the tool driver when the surgical tool isreceived in the mount.

A sterile adapter may be part of a sterile barrier system that furtherincludes a sterile drape. For example, a sterile barrier for use in arobotic surgical system may include a sterile adapter including a frameconfigured to be interposed between a tool driver and a surgical tool,where the frame has a frame perimeter, and at least one peripheralprojection may extend laterally around at least a portion of the frameperimeter (e.g., as a flange or partial flange). A sterile drape maythen be coupled to the projection, such as by thermal bonding or anothersuitable coupling process, to form at least part of the sterile barriersystem. In some variations, the peripheral projection may include aflexible elastomeric material, and the frame and the at least oneperipheral projection may be co-injection molded.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an illustrative schematic of a portion of a robotic surgicalsystem with a tool driver, surgical tool, and a sterile barrier.

FIGS. 2A-2C are various perspective views of one variation of a sterileadapter.

FIG. 3A is a perspective view of an exemplary subassembly of a tooldriver and a sterile adapter coupled to the tool driver. FIG. 3B is aperspective view of an exemplary subassembly of a tool driver, surgicaltool, and sterile adapter interposed between the tool driver and thesurgical tool.

FIG. 4A is a perspective view of one variation of a sterile adapter witha mount. FIG. 4B is a side view of an exemplary arrangement of asurgical tool coupled to the sterile adapter shown in FIG. 4A.

FIG. 5A is an illustrative schematic of a surgical tool in the processof coupling to another variation of a sterile adapter with a curvedmount. FIG. 5B is an illustrative schematic of the surgical tool coupledto the sterile adapter shown in FIG. 5A.

FIG. 6A is a perspective view of a variation of a sterile adapter with alocking member. FIG. 6B is a perspective view of an exemplaryarrangement of a tool driver and a surgical tool coupled to the sterileadapter shown in FIG. 6A. FIG. 6C is a perspective view of anothervariation of a sterile adapter with a locking member.

FIG. 7A is a perspective view of an exemplary arrangement of a tooldriver and a surgical tool coupled to a sterile adapter with adjustableshaft holes. FIGS. 7B-7D are illustrative schematics of various sizes ofadjustable shaft holes.

FIG. 8 is an illustrative cross-sectional schematic of a plate assemblywith rotatable couplers in one variation of a sterile adapter.

FIG. 9A is a perspective view of one variation of a sterile adapterincluding a series of tool engagement features. FIG. 9B is a front sideview of one variation of a surgical tool including a series of adapterengagement features for engaging with the series of tool engagementfeatures depicted in FIG. 9A. FIG. 9C is an exemplary angled profile ofadapter engagement features.

FIG. 10A is a front side view of an exemplary tool driver. FIG. 10B is aperspective view of one variation of a sterile adapter includingforce-transferring abutment features. FIG. 10C is a front side view ofan exemplary surgical tool. FIG. 10D is an illustrative sidecross-sectional view of a tool driver, a sterile adapter withforce-transferring abutment features, and a surgical tool.

FIG. 11A is a perspective view of one variation of a sterile adapterincluding a plate assembly with springs. FIG. 11B is a cross-sectionalschematic of a tool driver, a sterile adapter with springs, and asurgical tool.

FIG. 12A is a perspective view of one variation of a sterile adapterincluding a peripheral projection. FIG. 12B is a perspective view of asterile barrier including the sterile adapter depicted in FIG. 12A.

FIGS. 13A and 13B are perspective views of one variation of a rotatablecoupler in a sterile adapter.

FIG. 14A is an exploded schematic depicting engagement between an outputdrive of a tool drive, a coupler disc in a sterile adapter, and an inputdrive of a surgical tool. FIG. 14B is a cross-sectional schematic of theengaged combination of the components depicted in FIG. 14A.

FIGS. 15A-15G are illustrative schematics of an exemplary process ofcoupling a tool driver to one variation of a sterile barrier, andcoupling the sterile barrier to a surgical tool.

FIG. 16A is a perspective view and a side view, respectively, of anothervariation of a rotatable coupler in a sterile adapter. FIGS. 16B, 16Cand 16D are side, bottom and top views, respectively, of the rotatablecoupler variation depicted in FIG. 16A.

FIGS. 17A-17C illustrate an exemplary process of coupling a tool driverto one variation of a sterile adapter with a removable film.

FIGS. 18A-18D illustrate an exemplary variation of coupling a tool toanother variation of a sterile adapter.

FIGS. 19A and 19B illustrate an exemplary variation of decoupling a toolfrom the variation of a sterile adapter shown in FIGS. 18A-18D.

FIGS. 20A and 20B illustrate an exemplary variation of coupling a toolto another variation of a sterile adapter.

FIG. 21A is a front view of one variation of a sterile adapter. FIG. 21Bis a perspective view of one variation of a tool configured to engagethe sterile adapter depicted in FIG. 21A. FIG. 21C is an illustrativeschematic of the tool depicted in FIG. 21B in the process of beingattached to the sterile adapter depicted in FIG. 21A.

FIG. 22A is a perspective view of one variation of a sterile adapterwith drive couplers configured to be magnetically attracted to onevariation of a tool driver. FIG. 22B is a perspective view of onevariation of a surgical tool configured to be magnetically attracted tothe sterile adapter depicted in FIG. 22A.

FIGS. 23A and 23B are rear and front perspective views, respectively, ofone variation of a sterile adapter with an axially shifting plate inwhich the couplers of the sterile adapter are retracted. FIG. 23C is aperspective view of an exemplary surgical tool configured to engage withthe sterile adapter depicted in FIGS. 23A and 23B.

FIGS. 24A and 24B are rear and front perspective views, respectively, ofthe sterile adapter depicted in FIGS. 23A and 23B in which the couplersof the sterile adapter are extended. FIG. 24C is a perspective view ofan exemplary surgical tool configured to engage with the sterile adapterdepicted in FIGS. 24A and 24B.

FIGS. 25A and 25B are tool-side and tool driver-side perspective views,respectively, of another exemplary variation of a sterile adapter. FIG.25C is a tool-side view of the sterile adapter depicted in FIGS. 25A and25B. FIG. 25D is a tool driver-side view of the sterile adapter depictedin FIGS. 25A and 25B. FIGS. 25E and 25F are first and second sides of arotatable coupler. FIG. 25G is a cross-sectional view of the sterileadapter depicted in FIGS. 25A and 25B.

DETAILED DESCRIPTION

Examples of various aspects and variations of the invention aredescribed herein and illustrated in the accompanying drawings. Thefollowing description is not intended to limit the invention to theseembodiments, but rather to enable a person skilled in the art to makeand use this invention.

As shown generally in the schematic of FIG. 1, a portion of a roboticsurgical system includes a tool driver 10 configured to actuate asurgical tool 20. One or more drive outputs on the tool driver 10 may,for example, actuate one or more drive inputs on a proximal portion 22of the surgical tool 20, thereby causing movement (e.g., grasping,cutting, etc.) of an end effector located at a distal end of tool shaft24. Additionally, a sterile barrier 100 may be placed between the tooldriver 10 and the surgical tool 20, forming a barrier between aninterior, non-sterile side including the tool driver 10 and an exterior,sterile side including the surgical tool 20 which may, for example, belocated at a sterile surgical site. The sterile barrier 100 may, forexample, include a sterile drape 120 configured to cover at least thetool driver 10, and a sterile adapter 110 coupled to the sterile drape120 and located between the tool driver 10 and the surgical tool 20. Thesterile adapter 110 may be configured to communicate or otherwisetransmit actuation forces (e.g., rotary torque, linear movement, etc.)from at least one drive output of the tool to at least one drive inputof the surgical tool 20. Examples of sterile barriers 100, such asvariations of sterile adapters 110, are described in further detailherein.

Sterile Adapter

In one variation, as shown in FIGS. 2A-2C, a sterile adapter 200 mayinclude a frame 210 configured to be interposed between a tool driverand a surgical tool, a plate assembly 230 coupled to the frame 210, andat least one rotatable coupler 250 supported by the plate assembly andconfigured to communicate torque from an output drive of the tool driverto an input drive of the surgical tool.

In some variations, the sterile adapter may be configured to communicateelectrical signals, such as for communication and/or power (e.g., forsensors, etc.), between the tool driver and the surgical tool. Forexample, at least a portion of the sterile adapter, such as the frame,plate assembly, and/or at least one rotatable coupler may include metalcontacts for transferring electrical signals between the tool driver andthe surgical tool. Such metal contacts may, in some variations, mayadditionally or alternatively be used to signal to a controller and/orprocessor that the sterile adapter is coupled to the tool driver and/orto a surgical tool (in other variations, the tool driver and/or sterileadapter may include any suitable one or more sensors to detect thecoupling of the sterile adapter to the tool driver and/or surgical tool,such as a proximity sensor or a capacitive sensor). Additionally oralternatively, signals and/or power may be wirelessly communicated(e.g., Bluetooth or other wireless communication protocol) in anysuitable manner. For example, metal contacts may be omitted from thesterile adapter.

Frame

Generally, the frame 210 of the sterile adapter 200 may providestructural support for the sterile adapter 200, such as for detachablycoupling the sterile adapter 200 to a tool driver and/or a surgicaltool. For example, as shown in FIG. 2A, in one variation, the frame 210may include a first engagement feature 212 and/or a second engagementfeature 214. As shown in FIGS. 3A and 3B, the first engagement feature212 may be configured to couple the frame 200 to first end of a tooldriver 10, such as by including a lip that fits into a correspondinggroove in the tool driver via a snap fit or other suitable physicalinterference. Additionally or alternatively, the first engagementfeature 212 may include one or more magnets (not shown) such that thefirst engagement feature 212 may be guided and/or coupled to a suitablecorresponding feature on the tool driver 10 based on magnetic attractionbetween the magnets on the first engagement feature 212 and magnets onthe tool driver. Similarly, the second engagement feature 214 may beconfigured to couple the frame 210 to a second end of a tool driver 10,such as with a snap fit or other physical interference, and/or due toattractive magnetic forces. Although FIG. 2A depicts the firstengagement feature 212 and the second engagement feature 214 as being onopposite ends (e.g., a proximal end and a distal end) of the frame andcorresponding to opposite ends of the tool driver, it should beunderstood that the first engagement feature 212 and/or the secondengagement feature 214 may be on lateral sides and/or any suitable partof the frame 210. Furthermore, fewer (e.g., one) or more (e.g., three,four, five, etc.) engagement features may be included and distributedamong any suitable portions of the frame 210, with any suitablegeometries (e.g., grooves, hooks, tabs, latches, other snap fits, etc.).

Although the first and second engagement features 212 and 214 aredepicted generally as designed to couple to the tool driver via snap fittabs extending from an edge of the frame 210, other variations oflatching features or engagement features may be included. For example, asurface of the frame 210 may include a recess (e.g., channel, groove,hole, etc.) configured to receive and mate with a correspondingprojection (e.g., ridge, pin, etc.) on the outward (drive output) faceof the tool driver. The recess on the frame 210 may be sized relative tothe projection so as to enable coupling of the tool driver and the frame210 through an interference fit. Other features, such as angled barbs onthe projection of the tool driver, or compliant and/or frictionalelastomeric material on the projection or in the recess, may furtherfacilitate detachably coupling the sterile adapter to the tool driver.Similarly, as another example, a surface of the frame 210 may include aprojection configured to receive and mate with a corresponding recess onthe tool driver.

Furthermore, as shown in FIGS. 2A and 2B, the frame may further includeat least one tool engagement feature 216 configured to couple to aportion of a surgical tool. For example, as best shown in FIG. 3B, thetool engagement feature 216 may include a groove or other recessconfigured to receive a hook, lip or other overhanging projection orother feature of the surgical tool 20. In some variations, at least onetool engagement feature may be disposed on a proximal end (upper end asdepicted in FIG. 2B) of the frame 210. Furthermore, at least one toolengagement feature may additionally or alternatively be disposed on adistal end (lower end as depicted in FIG. 2B) of the frame 210. Like thefirst and second engagement features 212 and 214 described above, thetool engagement feature 216 may include other variations of features andmay be located at any suitable point on the frame 210.

As shown in FIGS. 2A-2C, generally, the frame 210 may further providestructural support for the plate assembly 230. For example, the frame210 may include one or more slots around the perimeter of the openingwithin which the plate assembly 230 sits, such that the edges of theplate assembly 230 may engage the one or more slots of the frame 210.The slots may be sized with a suitable amount of clearance for the plateassembly, such that the plate assembly may shift at least in a directiontransverse to the plane of the plate assembly, as described in furtherdetail below. In one variation, the slots may be wider than the plateassembly thickness such that the plate assembly 230 may freely movewithin the slots. In another variation, one or more springs may bepresent in at least one slot such that the plate assembly 230 moves withsome compliance.

As shown in FIGS. 2A-2C, the frame 210 may generally be rectangular, butmay have any suitable shape (e.g., rectangular with rounded corners,elliptical, circular, etc.). For example, the shape of the frame 210 maycorrespond with the shape of the tool driver and/or the shape of thesurgical tool to which the sterile adapter 200 is intended to couple. Insome variations, the frame may be made at least partially of a rigidplastic (e.g., polycarbonate, acrylonitrile butadiene styrene (ABS),nylon, a polycarbonate-ABS blend, etc.) which may or may not includereinforcement material (e.g., glass or carbon fiber reinforcement)and/or additives such as a lubricious additive (e.g.,polytetrafluoroethylene), talcum, etc. The frame may be injectionmolded, machined, 3D printed, or manufactured in any suitable process.

Mount

In some variations, the frame of the sterile adapter may include or becoupled to a projecting mount for receiving and coupling to the surgicaltool. For example, as shown in FIGS. 4A and 4B, a sterile adapter 400may include a body 410 configured to be interposed between a tool driverand a portion of a surgical tool, and a mount 420 projecting from thebody and configured to receive the portion of the surgical tool. Themount 420 may generally assist in coupling the surgical tool to thesterile adapter 400, in that it may serve as a seat or surface toreceive the surgical tool 20, such that when being coupled to thesterile adapter 400, the surgical tool 20 may contact the mount 420 foreasy, efficient positioning of the surgical tool 20 against the sterileadapter 400 into the arrangement shown in FIG. 4B.

The mount 420 may include a shaft hole 424 configured to receive a toolshaft 24 of the surgical tool 20 during and after coupling of thesurgical tool 20 to the sterile adapter 400. For example, the shaft hole424 may guide and receive a tool shaft 24 passing longitudinally throughthe shaft hole 424 and through the mount 420. In some variations, themount 420 may further include a shaft slot 426 configured to guide andreceive a tool shaft 24 passed laterally into or across the mount 420and into shaft hole 424. Furthermore, in some variations, the mount 420may include a raised rim 422 or lip that helps constrain the seatedportion of the surgical tool 22 (e.g., by preventing lateral sliding ofthe surgical tool). The raised rim 422 may extend around the entireperimeter of the mount 420 as shown in FIG. 4A. Alternatively, the mount420 may include multiple raised tabs similar to raised rim 422, exceptthat the multiple raised tabs may be distributed at a variety of pointsaround the entire perimeter of the mount 420 (e.g., only at the cornersand/or at some point along each edge of the mount 420). At least aportion of the shaft hole 424 and/or the shaft slot 426 may include anelastomeric or padded material where it contacts the tool shaft 24,which may frictionally reduce relative movement between the tool shaft24 and the sterile adapter and/or reduce potential damage to the toolshaft 24.

The shaft hole and/or the shaft slot may be adjustable to create apassageway for guiding different sizes of tool shafts 24 through themount. In one variation of a sterile adapter 700, as shown in FIG. 7A,the mount 720 may include one or more shutters 722 that adjust theopening size (e.g., diameter) of the shaft hole to center (and reducethe amount of misalignment, play, or “wiggling” of) different-sized toolshafts 24 passing through the mount. For example, as shown in FIG. 7C,the mount 720 may include a first shutter 722 a defining a passagewaycorresponding to a first tool shaft diameter, and a second shutter 722 bdefining a passageway corresponding to a second tool shaft diameter thatis larger than the first tool shaft diameter. As shown in FIG. 7D, themount 720 may include a shaft hole 724 defining a passagewaycorresponding to a third tool shaft diameter that is larger than thefirst and second tool shaft diameters. Fewer or more shutters 722 may beincluded to guide or correspond to fewer or more sizes of tool shaftdiameters. Each shutter may be operable between an inactive position (inwhich the shutter's passageway does not intersect with the path of thetool shaft 24) and an active position (in which the shutter's passagewaydoes intersect with the path of the tool shaft 24). One or more of theshutters may, for example, be configured to linearly slide in and out ofthe path of the tool shaft 24, or pivotably swing in and out of the pathof the tool shaft 24. One or more of the shutters may be spring-loadedto bias the shutter toward the tool shaft 24.

As shown in FIG. 7B, at least the first shutter 722 a may be urged intoits active position so as to permit a tool shaft 24 having the firsttool shaft diameter (or smaller) to pass through the mount. The secondshutter 722 b may (or may not) additionally be urged into its activeposition in order provide a tapered passageway to gradually guide thetool shaft 24 from the larger shaft hole 724 into the smaller passagewayprovided by the first shutter 722 a. The first shutter 722 a reduces theamount of possible misalignment and lateral movement experienced by atool shaft 24 having the first tool shaft diameter and passing throughthe first shutter 722 a. As shown in FIG. 7C, the first shutter 722 amay be retracted into its inactive position and the second shutter 722 bmay be urged into its active position, so as to permit a tool shaft 24having the second tool shaft diameter (or smaller) to pass through themount. The second shutter 722 b reduces the amount of possiblemisalignment and lateral movement experienced by a tool shaft 24 havingthe second tool shaft diameter and passing through the second shutter722 a. As shown in FIG. 7D, the first shutter 722 a and the secondshutter 722 b may be urged into their inactive positions so as to permita tool shaft 24 having the third tool shaft diameter (or smaller) topass through the shaft hole 724 of the mount. The shaft hole 724 may besized to reduce the amount of possible misalignment and lateral movementexperienced by a tool shaft 24 having the third tool shaft diameter.

In another variation of a sterile adapter having an adjustable shafthole size for the different tool shaft sizes, the mount may include aradially-adjustable shutter adjacent the shaft hole that accommodatesand adjusts to different tool shaft diameters. For example, theradially-adjustable shutter may include a leaf shutter with overlappingblades that progressively slide to constrict or expand the passagewayfor tool shaft 24. As another example, the radially-adjustable shuttermay include members that extend or are angled generally radially inwardsinto the shaft hole (or generally lean centrally toward the path of thetool shaft 24) to center the tool shaft 24 in the shaft hole. Themembers may, for example, be flexible (e.g., bristles, bendable fingers,etc.) such that they may bend less to accommodate smaller tool shaftsizes and bend more to accommodate larger tool shaft sizes. As yetanother example, the members may be radially-adjustable in length and/orangle (e.g., telescopic members, spring-loaded pinchers) such that theymay extend, retract, and/or pivot radially to accommodate different toolshaft sizes.

As shown in FIGS. 4A and 4B, in one variation, the mount 420 may includea substantially planar platform in order to accommodate a planar surfaceof the proximal portion 22 of the surgical tool 20. However, the mountmay have any suitable shape, which may correspond with, for example, theshape of the surgical tool 20 that it receives. For example, as shown inFIGS. 5A and 5B, a sterile adapter 500 may include a mount 520 that iscurved (e.g., semi-circular) to engage with a correspondingly curvedsurface of surgical tool 20, similar to a ball-and-socket joint. Anotherexample of a curved mount is shown in FIGS. 25A-25D and FIG. 25G. Mount2520 includes a medial section that is substantially planar, andincludes lateral curved sections extending beyond either side of themedial section. As shown FIG. 25G, the mount 2520 may be configured toreceive and/or engage with a tool 20, similar to the mounts describedabove. Furthermore, the mount may include multiple components, such as aplurality of extending arms or a latticework of multiple members, whichwork collectively to cradle or otherwise receive the proximal portion ofthe surgical tool.

As shown in FIGS. 4A and 4B, in one variation, the mount 420 may projectgenerally perpendicularly (about 90 degrees) from the body 410 of thesterile adapter frame. However, the mount 420 may project from the body410 at any suitable angle, which may depend on the shape of the surgicaltool 20 that is receives. For example, the profile of the portion of thesurgical tool to be received in the mount may include an angle orcurvature along its leading edge, and the mount 420 may becorrespondingly angled or curved to receive the surgical tool.

The mount 420 may enable multiple techniques for coupling the surgicaltool to the sterile adapter. Multiple techniques may be useful, forexample, to accommodate different user preferences and/or facilitateeasy tool swapping or exchange when the tool driver is in differentpositions or orientations (e.g., generally vertical, generallyhorizontal, or at other angles) and present different user accessoptions to the tool driver. For example, in one technique, a user mayguide the surgical tool generally longitudinally along the frame 410(and face of the plate assembly 430), allowing the tool shaft 24 to passlongitudinally through the shaft hole 424 and/or shaft slot 426 of thesterile adapter. The user may continue to guide the surgical toollongitudinally, until the proximal portion 22 of the surgical tool isseated in the mount 420 and/or the lip 23 of the surgical tool engagesthe engagement feature 416 of the tool driver, thereby coupling the tool20 to the sterile adapter 400 in the arrangement shown in FIG. 4B. Inanother exemplary technique, a user may guide the surgical toolgenerally laterally toward the tool-side face of the plate 430, allowingthe tool shaft 24 to pass through shaft slot 426 of the sterile adapterinto the shaft hole 424. The user may continue to guide the surgicaltool laterally, until at least a portion of the surgical tool contactsthe frame 410 and/or plate assembly 430, then subsequently guide thesurgical tool longitudinally until the surgical tool is seated in themount 420. In another exemplary technique, a user may angle the surgicaltool in its approach toward the sterile adapter (e.g., at 45 degreesrelative to the plate assembly) and guide the leading end of thesurgical tool toward the mount 420. Once the proximal portion 22 of thesurgical tool is in contact with the mount 420, the user may lean theproximal portion 22 back against the body 410 of the sterile adapteruntil the surgical tool is seated in the mount 420. Furthermore, othertechniques for coupling the tool and the sterile adapter may includecombinations of aspects of these techniques. Advantageously, couplingthe tool and the sterile adapter with the aid of a mount 420 is notlimited to one technique (e.g., solely the technique of longitudinallysliding the tool onto the sterile adapter), such that a user may selecta technique best suited for him or her, and/or best suited in aparticular circumstance where access to the tool driver may be limitedin a certain manner.

As shown in FIG. 4A, the body 410 and the mount 420 may be integrallyformed as one piece (e.g., injection molded, milled, etc.).Alternatively, the body 410 and the mount 420 may be formed as separatepieces, and the mount 420 may be coupled to the body with fasteners(e.g., screws), interlocking features such as interlocking tabs, epoxyor other suitable adhesive, and/or any suitable coupling method.

In some variations, the sterile adapter may further include a movablelocking member for securing the sterile adapter to the tool driver. Thelocking member may be selectively operable between an engaged positionand a disengaged position. In the engaged position, the locking membermay secure a coupling of the frame to the tool driver. In the disengagedposition, the locking member may facilitate a decoupling of the framefrom the tool driver.

For example, in one variation as shown in FIGS. 6A and 6B, a sterileadapter 600 may include a locking member 630. The locking member may becoupled to a body 610 and/or mount 620 of the sterile adapter 600. Thelocking member 630 may include at least one end 630 a configured tocouple to the tool driver 10, such as with an engagement feature 632(e.g., an opening or recess configured to engage with a projection onthe tool driver 10). The locking member 630 may include, for example, alever that pivots around Axis A to toggle between an engaged positionand a disengaged position. In one variation as shown best in FIG. 6B,the locking member 630 may further include a second end 630 b configuredto engage or otherwise contact the tool (e.g., the second end 630 b mayinclude the shaft hole 624 through which tool shaft 24 passes when thesurgical tool 20 is seated in the mount 620), such that the disengagedposition is blocked when the portion of the surgical tool is received inthe mount. Accordingly, the locking member 630 may prevent decoupling ofthe sterile adapter 600 from the tool driver when the surgical tool isreceived in the mount. This kind of “lockout” feature may beadvantageous, for example, during tool exchange in order to help ensurethat the sterile adapter 600 remains in place (e.g., significantlyreduce the likelihood that the sterile adapter is inadvertentlydecoupled from the tool driver) when surgical tools are swapped in andout of the sterile adapter frame and mount. Although the locking member630 is generally depicted as a lever in FIGS. 6A and 6B, it should beunderstood that in other variations, other members or mechanismsincluded or coupled to the sterile adapter may require movement into thespace occupied by the surgical tool 20 in order to decouple the sterileadapter from the tool driver.

Alternatively, in another variation as shown in FIG. 6C, the lockingmember 630′ may be configured to freely toggle between an engagedposition and disengaged position regardless of the presence of thesurgical tool. For example, a user may push a projection 634 in thedirection indicated by the arrow B in order to decouple the first end630 a of the locking member from the tool driver 10. Similarly, as shownin FIG. 25G, a locking member 2531 may be configured to receive and/orengage with at least a portion of the tool driver 10. The locking member2531 may include a projection 2534 that a user may push in order todecouple the locking member from the tool driver 10.

Drape Attachment

In some variations, a sterile adapter may include a frame configured tobe interposed between a tool driver and a surgical tool, wherein theframe has a frame perimeter, and at least one peripheral projectionextending laterally around at least a portion of the frame perimeter.The peripheral projection may provide a surface to which a sterile drapemay be coupled or attached, such that in combination the sterile adapterand the sterile drape form a sterile barrier. For example, as shown inFIG. 12A, a sterile adapter 1200 may include a frame 1210 configured tobe interposed between a tool driver 10 and a surgical tool 20, and aperipheral projection 1260 extending laterally and around substantiallythe entirety of the perimeter or boundary of the frame 1210. As shown inFIG. 12B, a sterile drape 1270 may be coupled to the peripheralprojection 1260, such as through thermal bonding, thereby forming asterile barrier that may be used to cover the tool driver while enablingthe tool driver 10 to actuate the surgical tool 20 via the rotatablecouplings in the sterile adapter 1200.

The peripheral projection 1260 may extend a suitable distance forproviding sufficient surface area for coupling the sterile drape 1270 tothe peripheral projection 1260. For example, the peripheral projection1260 may extend between about 0.2 cm and about 1.5 cm, between about 0.5cm and about 1.0 cm, or between about 0.5 cm and 0.7 cm (e.g., about 0.6cm), etc. in order to provide enough surface area for thermal bonding oranother suitable coupling method to bond the sterile drape to thesterile adapter via the peripheral projection.

In some variations, the peripheral projection 1260 may include adifferent material than the frame 1210. For example, as described above,the frame 1210 may be made of a material that is relatively rigid, suchas polycarbonate or ABS, while the peripheral projection 1260 mayinclude a relatively more flexible material, such as a compliantelastomer such as a suitable thermoplastic elastomer (e.g., MEDIPRENE,SANTOPRENE, etc.). The flexible material of the peripheral projection1260 may, for example, provide a rigid enough platform to allow forsterile drape attachment during assembly of the sterile barrier (orsufficiently rigid when back-supported during drape attachment with afixture, etc.), while also being deformable (e.g., similar to a livinghinge) to enable the sterile adapter to be more compact if needed (e.g.,to enable adjacent or side-to-side placement of multiple tool driversand/or surgical tools during a surgical procedure, therebyadvantageously increasing available positioning and mobility of therobotic system). The sterile drape may be made of urethane or othersuitable material.

One exemplary method of making a sterile adapter with a peripheralprojection includes co-injection molding a frame and at least oneperipheral projection that extends laterally around at least a portionof the perimeter of the frame, and coupling a sterile drape to theperipheral projection. The co-injection molding may include introducinga first material into a first portion of a mold corresponding to theframe, and introducing a second material that is less rigid than thefirst material into a second portion of the mold corresponding to theperipheral projection. Coupling the sterile drape to the peripheralprojection may include thermal bonding, epoxy or other adhesive,fasteners, or any suitable attachment method.

In some variations, the frame may include multiple layers of peripheralprojections. For example, the frame may include a first peripheralprojection and a second peripheral projection overlying the firstperipheral projection. The two layers of peripheral projections (eachsubstantially similar to peripheral projection 1260, for example) maysandwich or clamp upon the sterile drape. The peripheral projections maybe coupled together to secure the sterile drape between the peripheralprojections, such as with thermal bonding, epoxy, etc.

Plate Assembly

The plate assembly functions to provide structural support for one ormore rotatable couplers (e.g., discs as described in further detailbelow). For example, as shown in FIGS. 2A-2C for example, the plateassembly 230 may generally be disposed within an opening of the frame210 and provide structural support for a plurality of rotatable couplers250. Additionally or alternatively, the plate assembly may interact withthe tool driver and/or surgical tool, such as to facilitate alignment,distribute load forces, etc.

As shown in an illustrative cross-sectional schematic of FIG. 8, in onevariation, a sterile adapter 800 may include a frame 810 and a plateassembly 830 disposed within the frame 810. The plate assembly 830 mayinclude at least one opening 840 for receiving a rotatable coupler 850.For example, the plate assembly 830 may include six openings 840 forreceiving six rotatable couplers 850, though fewer (e.g., two, three,four, or five) or more (e.g., seven, eight, nine, or ten or more)openings 840 may be included in the plate assembly 830. The plateassembly may include multiple plates layered and coupled together. Forexample, as shown in FIG. 8, the plate assembly 830 may include a tooldriver-side plate 832 and a tool-side plate 842. The multiple plates maybe assembled around the rotatable couplers 850 so as to contain thecouplers 850 within the openings 840, such as by coupling the tooldriver-side plate 832 and the tool-side plate 842 with fasteners (e.g.,screws, etc.), brackets, epoxy or other adhesive, and/or any suitablecoupling mechanism. Alternatively the plate assembly may be oneintegrally formed piece to include openings 840. The openings 840 may besized and shaped to permit the rotatable couplers 850 to move transverseto the plane of the plate assembly (i.e., up and down in the orientationshown in FIG. 8), and/or laterally generally within the plane of theplate assembly with low friction, while still being constrained in theopening 840. The plate assembly may include, for example, a rigidplastic or other suitable rigid material (e.g., polycarbonate, ABS, orother materials and compositions described above for the frame,aluminum, stainless steel or other suitable sheet metal, etc.), Like theframe, the plate assembly may be injection molded, machined, extruded,stamped, 3D printed, or manufactured in any suitable manner

Tool Engagement Features

In some variations, the plate assembly may include one or more alignmentfeatures that help ensure that the surgical tool is properly alignedwith the sterile adapter before the surgical tool and sterile adaptercouple to one another. In one variation, the plate assembly may includea series or pattern of one or more tool engagement features (e.g., on atool-side plate of the plate assembly), where each tool engagementfeature is mateable with a corresponding adapter engagement feature onthe surgical tool. For example, at least one tool engagement feature maybe mateable to a corresponding adapter engagement feature in a unique1:1 pairing, and successful mating of the paired features may berequired to enable the sterile adapter to couple to the surgical tool.Furthermore, in variations in which all of the tool engagement featureshave a respective unique 1:1 pairing with a corresponding adapterengagement feature, the sterile adapter (e.g., the frame) may beconfigured to couple to the surgical tool only when each and every toolengagement feature is mated with its corresponding adapter engagementfeature on the surgical tool. Each of the tool engagement features mayinclude a channel or recess of differing size (e.g., length, width,etc.) and/or shape (e.g., straight, curved, wavy, chamfered or notchamfered, etc.), and similarly, each of the adapter engagement featuresmay include an outward projection of differing size and/or shape toengage with a respective tool engagement feature on the sterile adapter.In some variations, each (or at least one) of the tool engagementfeatures may include a projection of differing size and/or shape, whileeach (or at least one) of the adapter engagement features may include achannel of differing size and/or shape to engage with a respective toolengagement feature on the sterile adapter.

In one example, the plate assembly 930 may include recessed toolengagement features 944 a, 944 b, 944 c, and 944 d as shown in FIG. 9A,and the surgical tool 20 may include outwardly projecting adapterengagement features 26 a, 26 b, 26 c, and 26 d. Tool engagement features944 a, 944 b, 944 c, and 944 d may be configured to uniquely mate withadapter engagement features 26 a, 26 b, 26 c, and 26 d, respectively.Furthermore, the tool engagement features 944 a-944 d may be arranged ina series (e.g., sequential pattern or in another pattern), such asarranged by increasing width or length along a direction of toolinsertion (e.g., longitudinally along the plate assembly 930 indicatedby arrow C in FIG. 9A), though other patterns may possible in othervariations. Only upon mating of each of these pairings is the sterileadapter permitted to fully couple to the surgical tool 20. Until thisholistic mating occurs, the outwardly projecting adapter engagementfeatures 26 a-26 d may physically interfere with the tool-side plate ofthe plate assembly 930, thereby urging the plate assembly 930 and thesterile adapter couplers 950 away from the surgical tool and its inputcouplers 28 and thus preventing coupling between the sterile adapter andthe surgical tool. A similar coupling prevention effect may be achievedin a variation in which the tool engagement features 944 a-944 d areoutwardly projecting and the adapter engagement features 26 a-26 d arerecessed.

In one exemplary technique for coupling the tool 20 to the sterileadapter 900, the tool 20 may be moved longitudinally along the plateassembly 930, with the adapter engagement feature 26 d encountering thetool engagement features 944 a, 944 b, and 944 c, in that order, withoutmating due to physical interference (e.g., size and/or shape mismatch).Similarly, adapter engagement feature 26 c encounters the toolengagement features 944 a and 844 b, and adapter engagement feature 26 bencounters the tool engagement feature 944 a, without mating due tophysical interference. During this stage, the physical interference alsopushes against and displaces the plate assembly 930 and its couplers 950away from the surgical tool 20, thereby further preventing couplingbetween the sterile adapter 900 and the tool 20. After the tool 20 isfurther moved in the tool insertion direction, the adapter engagementfeature 26 d encounters the tool engagement feature 944 d, as do theadapter engagement features 26 a-26 c with their respective toolengagement features 944 a-944 c. When all of the tool engagementfeatures align and mate with their corresponding adapter engagementfeatures, the sterile adapter 900 may couple to the surgical tool 20.

Furthermore, a projection on the plate assembly 930 or tool 20 (whetheras a tool engagement feature or an adapter engagement feature) may havean angled profile (e.g., an angled fin) relative to the direction oftool insertion so as to help reduce physical interference during whenthe surgical tool 20 is sliding along the sterile adapter. For example,as shown in FIG. 9C, the adapter engagement features 26 a and 26 b onthe surgical tool may be outward projections angled away from thedirection of tool insertion indicated by arrow C in FIG. 9A, therebymaking it easier for the tool to slide down onto the mount of thesterile adapter. Alternatively, the tool engagement features 944 a-944 don the sterile adapter may be outward projections that are angled towardthe direction of tool insertion, thereby making it easier for thesterile adapter to receive a tool sliding down onto the mount of thesterile adapter.

Although FIG. 9A depicts a plate assembly 930 having four toolengagement features, in other variations, there may be any suitablenumber of tool engagement features and adapter engagement features(e.g., one, two, three, five, six, seven, eight, or more of each).Furthermore, the tool engagement features may vary in width and/orshape. For example, as shown in FIG. 25C, plate assembly 2530 includestwo tool engagement features 2544 a and 2544 b along the length of theplate assembly 2530, wherein a first tool engagement feature 2544 a isshorter and narrower than a second tool engagement feature 2544 b.Furthermore, while the tool engagement features on the sterile adapterare arranged in a linear series of progressively increasing width in thevariation depicted in FIG. 9A, in other variations the tool engagementfeatures may be in other suitable patterns (e.g., zig-zag, random,radial or concentric, etc.).

Force Transfer Features

In some variations, the plate assembly may include one or more abutmentsconfigured to transfer force received by the sterile adapter from thetool. For example, a surgical tool may be configured to deliver a forcedirected along a longitudinal axis of the surgical tool (e.g., thedirection along the tool shaft 24), and the axial force may betransferred to the sterile adapter via the coupling between the sterileadapter and the surgical tool (e.g., via the mating of adapterengagement features on the tool to the tool engagement features on thesterile adapter, as described above). To prevent the sterile adapterfrom having to absorb this axial force (which may, for example, causedamage to the frame of the sterile adapter), the sterile adapter mayinclude force transfer features abutting the tool driver, so as to causethe axial force to be transferred to the tool driver, which may begenerally more robust than the sterile adapter and able to withstandsuch forces without damage.

One or more of the abutments may be an outward projection on a tooldriver-side plate of the plate assembly that engages a recess in thetool driver 10. Additionally or alternatively, one or more of theabutments may be a wall of a recess in the tool driver-side plate of theplate assembly configured to receive an outward projection on the tooldriver 10. For example, as shown in FIG. 10B, a sterile adapter 1000 mayinclude a plate assembly 1030 with one or more outwardly projectingribs, such as ribs 1034 a and 1034 b. The ribs 1034 a and 1034 b mayengage and abut receptacles 14 a and 14 b, respectively, which are shownin FIG. 10A. Accordingly, when the tool driver 10, the sterile adapter1000, and the tool driver 20 are engaged in combination, axial forcesexperienced by the tool 20 may be delivered to the sterile adapter 1000(e.g., via adapter engagement features 26 a-26 c) and thereaftertransferred to the tool driver 10 (e.g., via ribs 1034 a and 1034 b).Similar to the tool engagement features 944 a-944 d and/or adapterengagement features 26 a-26 d described above with reference to FIG. 9B,the outwardly projecting ribs 1034 a and/or 1034 b may be elongated andangled in profile, though they may have any suitable shape havingsufficient surface area for abutting the tool driver.

FIG. 10D illustrates one variation in which the abutments (e.g., ribs)of the plate assembly may resolve or redirect axial forces from the toolto the tool driver. The adapter engagement features 26 c and 26 d on thesurgical tool 20 may engage the tool engagement features 1024 c and 1024d (which may be similar to the tool engagement features 944 a-944 ddescribed above) on the sterile adapter such that the plate assemblyreceives the axial force delivered by the tool (e.g., forces in thedirection of arrow D) via tool engagement features 1024 c and 1024 d.Movement of the plate assembly is prevented at least in part by theabutment of ribs 1034 a and 1034 b against receptacles 14 a and 14 b,which also results transfer of the axial force from the sterile adapterto the tool driver 10. In some variations, at least some of the toolengagement features on the sterile adapter, such as tool engagementfeatures 1024 c and 1024 d may be aligned with the ribs 1034 a and/or1034 b, so as to provide a more direct path for transferring forces fromthe tool to the tool driver. For example, as shown in FIG. 10D, the toolengagement feature 1024 c is aligned with the rib 1034 b. In othervariations, the tool engagement features need not be aligned with theforce-transferring abutments.

Such a transfer of the axial force may, for example, prevent potentiallydamaging loads from being transferred to the frame 1010 of the sterileadapter 1000. Accordingly, the frame 1010 may advantageously be madesmaller and lighter since it does not have to be robust enough towithstand the axial force. Furthermore, in some variations, theforce-transferring features in the sterile adapter may result in lesscompliance or play in the overall tool driver, sterile barrier, andsurgical tool assembly, as well as more accurate actuation of thesurgical tool by the tool driver (especially when the tool isexperiencing force loads).

Springs

The plate assembly may, in some variations, include one or more springsconfigured to urge or bias the plate assembly toward the surgical tool20 and away from the tool driver 10. For example, as shown in FIG. 11A,a sterile adapter 1100 may include a plate assembly 1130 including aplurality of springs 1136 located on a tool driver-side plate of theplate assembly 1130. The springs 1136 may include, for example, a beamspring, a coil spring, a leaf spring, a compliant material (e.g., anelastomeric material), and/or any suitable mechanism or material thatprovides a spring force resistant to deformation. In some variations,one or more of the springs 1136 may be integrally formed with the plateassembly 1130 (e.g., through injection molding). As shown in FIG. 11B,when the tool driver 10, the sterile adapter 1100, and the surgical tool20 are assembled in combination, the springs 1136 may be configured topush off the sterile adapter-facing surface of the tool driver 10 andpush the plate assembly 1130 away from the tool driver 10, therebybringing the plate assembly 1130 closer to the surgical tool 20.

The one or more springs 1136 may, for example, help encourage couplingbetween the sterile adapter and the surgical tool before the sterileadapter's rotatable couplers 1150 fully engage with the input drive ofthe surgical tool (not shown), such as to help prevent the surgical toolfrom separating fully (e.g., falling off) of the sterile adapter. Asanother example, the spring may help keep the rotatable couplers 1150positioned within the plate assembly with a clearance gap, so as toavoid frictional ribbing of the couplers 1150 against surfaces of theplate assembly during tool driving. The operation of the one or moresprings on the plate assembly is further described below with respect tothe sequence of engagement and disengagement of the sterile adapter'srotatable couplers with the tool drive and surgical tool.

Rotatable Couplers

The rotatable couplers (e.g., coupler discs) are supported by the plateassembly as described above. The rotatable couplers are configured tocommunicate torque from a tool driver to a surgical tool. Each couplermay include, for example, a body (e.g., disc) configured to beinterposed between an output drive of the tool driver and an input driveof the surgical tool. The body may include a first face having a firstengagement feature configured to engage the output of drive of the tooldriver, and may further include a second face having a second engagementfeature configured to engage the input drive of the surgical tool. Thefirst and second engagement features may be different in shape. Forexample, in some variations, the body may include a first face defininga first recess and a second face defining a second recess, where thefirst recess and the second recess are different in shape. As anotherexample, in some variations, the body may include a first face having afirst projection and a second face having a second projection, where thefirst and second projections are different in shape. In some variations,the body may include a first face having a first arcuate feature (e.g.,channel or projection) configured to engage the output drive of the tooldriver, and may further include a second face having a second arcuatefeature (e.g., channel or projection) configured to engage the inputdrive of the surgical tool. The first and second arcuate features mayhave different arc lengths.

In one exemplary variation, the body may include a tool driver-side face1310 as shown in FIG. 13A and a tool-side face 1350 as shown in FIG.13B. The tool driver-side face 1310, as shown in FIG. 13A, may include afirst arcuate feature 1312 and one or more first drive features 1314.The tool-side face 1350, as shown in FIG. 13B, may include a secondarcuate feature 1352 and one or more second drive features 1354. Each ofthe first and second arcuate features 1312 and 1352 may, for example, bea circular segment. Furthermore, the first and second arcuate features1312 and 1352 may be circular segments (e.g., a “C”-shape) that arecentered about an axis of rotation of the body. In one variation, thefirst and second arcuate features 1312 and 1354 are arcuate channels forengaging outward projections on the output drive of the tool driver andthe input drive of the surgical tool. However, it should be understoodthat additionally or alternatively, the tool driver-side face 1310and/or the tool-side face 1350 may include an outward projection thatengages a corresponding arcuate channel on the tool driver output driveor the surgical tool input drive.

The arcuate features 1312 and 1354 rotationally position the rotatablecouplers for engagement with the tool driver and the surgical tool. Forexample, the arcuate features may at least partially function to ensurethat there is a single rotational orientation of the rotatable coupler1300 relative to an output drive of a tool driver and an input drive ofa surgical tool. As shown best in FIG. 14A, the first arcuate feature1312 on the tool driver-side face of the coupler body may be configuredto mate with a corresponding arcuate feature 1416 on an output drive1412 of a tool driver. For example, the coupler arcuate feature 1312 andthe output drive arcuate feature 1416 may sweep approximately equalangles such that there is only one relative rotational position in whichthe coupler arcuate feature 1312 and the output drive arcuate feature1416 may mate and engage. Similarly, as shown in FIG. 14A, the secondarcuate feature 1352 on the tool-side face of the coupler body may beconfigured to mate with a corresponding arcuate feature 1424 on an inputdrive 1422 of a surgical tool. For example, the coupler arcuate feature1252 and the input drive arcuate feature 1426 may sweep approximatelyequal angles such that there is only one relative rotational position inwhich the coupler arcuate feature 1352 and the input drive arcuatefeature 1426 may mate and engage. When the output drive 1412 is coupledto the input drive 1422 via the rotatable coupler 1300 as describedabove and shown in the cross-sectional view in FIG. 14B, the rotatablecoupler 1300 may communicate torque from the output drive of the tooldriver to the input drive of the surgical tool, such that the tooldriver actuates or drives the surgical tool.

The first and second arcuate features may have different arc lengths.Furthermore, the sum of the central angle swept by the first arcuatefeature 1312 and the central angle swept by the second arcuate feature1352 may be equal to about 360 degrees, or a full circle. For example,one of the arcuate features on the body (e.g., the first arcuate feature1312) may sweep a major arc, (i.e., is a major arc more than 180degrees, such as an angle that is between about 181 degrees and about270 degrees), while the other arcuate feature (e.g., the second arcuatefeature 1354) on the body may sweep a minor arc (i.e., is a minor arcless than 180 degrees, such as an angle that is between about 90 degreesand about 179 degrees). In variations in which one of the first arcuatefeature 1312 or the second arcuate feature 1352 sweeps a major arc thatis more than 180 degrees and the other sweeps a minor arc that is lessthan 180 degrees, the first and second arcuate features may helpmaintain in-plane rotation of the coupler 1300 during driving. Forexample, with reference to FIG. 14A, when the output drive arcuatefeature 1416 is received in the first coupler arcuate feature 1312 andthe input drive arcuate feature 1426 is received in the second couplerarcuate feature 1352, the output drive disc 1412 and input drive disc1422 may be substantially prevented from tilting or leaning toward eachother, due at least in part to physical interference between outputdrive arcuate feature 1416 and the input drive arcuate feature 1426through the intervening surfaces of the coupler disc 1300 arcuatefeatures. Thus, the coupler 1300 may maintain substantial co-planarmotion (e.g., without precession), which also helps keep the outputdrive disc 1412 and the input drive disc 1422 substantially parallel,thereby improving accuracy of actuation of the surgical tool.

The tool driver-side face 1310 may further include one or more firstdrive features 1314 as shown in FIG. 13A, and the tool-side face 1350may further include one or more second drive features 1354 as shown inFIG. 13B. The drive features 1314 and 1354 may include, for example, pinholes or recesses (square, round, etc.) configured to engage withoutward projecting drive pins on the output drive of the tool driver andon the input drive of the surgical tool. However, it should beunderstood that additionally or alternatively, the tool driver-side face1310 and/or the tool-side face 1350 may include an outward projectingdrive pin that engages a corresponding hole or recess on the tool driveroutput drive or the surgical tool input drive. Furthermore, the drivefeatures 1314 and 1354 may include chamfers to help guide engagementwith corresponding drive features on the tool driver and/or surgicaltool. In one variation, the body includes two drive features 1314 on itstool driver-side face arranged about 180 degrees from one another, andtwo drive features 1354 on its tool-side face arranged about 180 degreesfrom another. The set of the two drive features 1314 and the set of thetwo drive features 1354 may be rotationally offset by about 90 degrees(e.g., a first drive feature 1314 located at about 0 degrees, a seconddrive feature 1354 located at about 90 degrees, another first drivefeature 1314 located at about 180 degrees, and another second drivefeature 1354 located at about 270 degrees). A rotational offset of about90 degrees may, in some variations, permit and help compensate for axialmisalignment between the output drive of the tool driver and the inputdrive of the surgical tool (e.g., operating similarly to a floating discin an Oldham coupler). Furthermore, the first drive features 1314 may,in some variations, be equidistant from the axis of rotation of thecoupler 1300, and similarly the second drive features 1354 may beequidistant from the axis of rotation of the coupler.

The first and second drive features 1314 and 1354 may be disposed nearthe edge or perimeter of the coupler body, so as to maximize torquetransferred from the tool driver to the surgical tool through thecoupler 1300. For example, with reference to FIG. 14A, the first drivefeatures 1314 (not shown in FIG. 14A) on the coupler 1300 may beconfigured to receive the output drive pins 1414 on the output drive1412. The second drive features 1354 on the coupler 1300 may beconfigured to receive the input drive pins 1424 on the input drive 1422.Accordingly, when the output drive 1412 is coupled to the input drive1422 via the rotatable coupler 1300 as shown in the cross-sectional viewin FIG. 14B, the rotatable coupler 1300 may communicate torque from theoutput drive of the tool driver to the input drive of the surgical tool,such that the tool driver actuates or drives the surgical tool. Althoughthe drive features 1314 and 1354 on the coupler 1300 may be the primaryfeatures for communicating torque, the arcuate features 1312 and 1352 onthe coupler 1300 may also communicate some amount of torque by virtue ofalso engaging with the output drive of the tool driver and the inputdrive of the surgical tool.

As shown in FIGS. 13A and 13B, the coupler body may further include anouter flange 1360 that helps retain and/or position the coupler 1300within the plate assembly. The outer flange 1360 may be substantiallycontinuous around the perimeter of the coupler body, thoughalternatively may include discrete segments (e.g., tabs) distributedaround the perimeter of the coupler body. Furthermore, the outer flange1360 may include one or more frictional features, such as on thetool-side face 1350 of the outer flange 1360, that may help reduce theamount of free spin of the coupler 1300 within the plate assembly whendesired (e.g., during selected parts of the coupling process in whichthe coupler 1300 engages the surgical tool, as described in furtherdetail below). In some variations, the tool driver-side face 1310 of theouter flange 1360 may additionally or alternatively include one or morefrictional features. Examples of frictional features include raisedbumps 1370 as shown in FIG. 13B, a wavy or undulating outer flangeprofile, an elastomeric or other high friction material (e.g., pads,co-injected, overmolded, etc.) on the outer flange 1360, etc.

As shown in FIGS. 16A and 16B, another exemplary variation of arotatable coupler 1600 in a sterile adapter (e.g., for placement in ashifting plate assembly) may include a first coupler portion 1610configured to engage an output drive of a tool driver and a secondcoupler portion 1650 configured to engage an input drive of a surgicaltool. First and second coupler portions 1610 and 1650 may be separatepieces that are coupled or affixed together (e.g., with epoxy or othersuitable adhesive, thermal molding, press-fit of pins or other joiningfeatures, etc.). Alternatively, first and second coupler portions 1610and 1650 may be integrally formed, such as through injection molding orbeing machined as one piece.

Similar to the rotatable coupler 1300 described above with reference toFIGS. 13A and 13B, the rotatable coupler 1600 may incorporate one ormore arcuate features (e.g., at least one recess and/or outwardprojection sweeping a major arc, or appearing in a “C”-shape) to providea single rotational alignment relative to an output drive disc on a tooldrive and relative to an input drive disc on a surgical tool. Thearcuate features may also help keep the coupler 1600 rotating insubstantially a single plane. Additionally, similar to the rotatablecoupler 1300, the rotatable coupler 1600 may incorporate drive features(e.g., pins located as far as possible from a central axis of rotationof the coupler body) to communicate driving torque from an output driveon a tool drive to an input drive on a surgical tool. Furthermore, likethe rotatable coupler 1300, the rotatable coupler 1600 may include anouter flange 1660 configured to help retain and position the rotatablecoupler 1600 within a plate assembly.

For example, FIG. 16C depicts a tool driver-side face (i.e., configuredto face and engage the tool driver) of the first coupler portion 1610.The tool driver-side face of the first coupler portion 1610 may includean arcuate feature 1612 configured to engage with a correspondingarcuate feature on a tool driver (not shown) and drive features 1614(e.g., holes) configured to engage with corresponding drive features(e.g., pins) on the tool driver. Furthermore, FIG. 16D depicts atool-side face (i.e., configured to face and engage the surgical tool)of the second coupler portion 1650. The tool-side face of the secondcoupler portion 1650 may include an arcuate feature 1652 configured toengage with a corresponding arcuate feature on a surgical tool (notshown) and drive features 1654 (e.g., holes) configured to engage withcorresponding drive features (e.g., pins) on the surgical tool.

In some variations, the first coupler portion's drive features 1614 maybe offset about 90 degrees from the second coupler portion's drivefeatures 1654. For example, the first and second coupler portions 1610and 1650 may be different instances of the same design (e.g., same sizeand shape) but rotated and affixed to one another with an approximately90-degree rotational offset. This rotational offset may permit and helpcompensate for axial misalignment between the output drive of the tooldriver and the input drive of the surgical tool (e.g., operatingsimilarly to a floating disc in an Oldham coupler). At least some of thedrive features on the coupler 1600 may be elongated or slot-like, whichmay provide some tolerance accommodation and compensation for axialmisalignment between the output drive of the tool driver and the inputdrive of the surgical tool. For example, the drive features 1614 on thefirst coupler portion 1610 may be somewhat elliptical to enable thecoupler 1600 to translate around a circular drive pin on the tool driveras the coupler 1600 rotates, while additionally the drive features 1654on the second coupler portion 1650 may be somewhat elliptical to enablethe coupler 1600 to translate around a circular drive pin on thesurgical tool. Thus, the drive features 1614 and 1654 may be able tocompensate for axial misalignment.

Another exemplary variation of a rotatable coupler 2550 in a sterileadapter (e.g., for placement in a shifting plate assembly) is shown inthe sterile adapter 2500 depicted in FIGS. 25E and 25F. A first face(e.g., tool driver-side face) of the rotatable coupler 2550 is shown inFIG. 25E, while a second face (e.g., tool-side face) of the rotatablecoupler 2550 is shown in FIG. 25F. Furthermore, the rotatable coupler2550 may include an outer flange 2560 similar to the outer flange 1360described above with respect to FIGS. 13A and 13B. As shown in FIG. 25G,one or more rotatable couplers 2550 may be supported by a plate assembly2530 in a frame 2510, similar to that described elsewhere herein.

As shown in FIG. 25E, the first face of the rotatable coupler mayinclude at least one engagement feature 2562 for engaging with an outputdrive of a tool driver. The engagement feature 2562 may include acentral feature (e.g., recess or projection) that is substantiallycentered on an axis of rotation of the rotatable coupler. As shown inFIG. 25F, the second face of the rotatable coupler 2500 may include atleast one engagement feature 2564. The engagement feature 2564 mayinclude an arcuate feature (e.g., recess or projection, such as anarcuate channel or arcuate projection) similar to those described abovewith respect to couplers 1300 and 1600. As shown in FIG. 25F, the secondface of the rotatable coupler 2500 may include two engagement features2564 and 2564′ (e.g., one engagement feature disposed on each side of adrive feature 2574, described below). In other variations, the rotatablecoupler 2500 may include any suitable number of engagement features onthe first side and/or second side of the coupler 2500.

In some variations, the engagement features 2562 and 2564 may extend inopposite axial directions. For example, as shown best in the perspectiveviews of FIGS. 25A and 25B, both of the engagement features 2562 and2564 may be recesses (e.g., channels) that extend inwards in oppositedirections in the rotatable coupler. Alternatively, the engagementsfeatures 2562 and 2564 may be projections (e.g., ridges) that extendoutwards in opposite directions in the rotatable coupler.

In some variations, the coupler 2550 may include one or more drivefeatures (e.g., similar to drive features described above for coupler1300 and coupler 1600). For example, similar to coupler 1300, the tooldriver-side face of coupler 2550 shown in FIG. 25E may include one ormore first drive features 2572 (e.g., cutouts), and the tool-side faceof coupler 2550 shown in FIG. 25F may include one or more second drivefeatures 2574 (e.g., cutouts). The set of the drive features 2572 andthe set of the drive features 2574 may be rotationally offset by about90 degrees, similar to that described above with respect to coupler1300. However, the drive features may be sized, shaped, and arranged inany suitable manner.

The rotatable couplers (e.g., coupler 1300, coupler 1600, coupler 2550)may include polycarbonate, ABS, other materials described above for theframe and/or plate assembly, or other suitable rigid material which maybe injection molded, machined, extruded, stamped, 3D printed, ormanufactured in any suitable manner.

Sterile Adapter Coupling and Decoupling

An exemplary method for coupling and engaging the sterile adapterdescribed above to a tool driver and/or tool drive is generally depictedin FIGS. 15A-15G. As shown in FIG. 15A, a sterile adapter may include aframe 1520 that houses a plate assembly 1510. The plate assembly 1510may include a tool driver-side plate 1512 and a tool-side plate 1514,and the plate assembly may support one or more rotatable couplers orcoupler discs 1300 disposed between the plates 1512 and 1514 withsuitable axial and rotational clearance. Furthermore, a tool driver 1410may include one or more output drive discs 1412 configured to mate andengage with one or more corresponding coupler discs 1300.

In FIG. 15A, the frame 1520 is attached to the tool driver 1410, but asshown in more detail in FIG. 15B, the output drive discs 1412 are notyet engaged with the coupler discs 1300. As shown in FIG. 15B, theoutput drive disc 1412 is biased upward against the coupler disc 1300due to a biasing force (e.g., provided by a spring in the tool driverthat spring-loads the output drive disc 1412, and/or at least one magnetthat causes an attraction between the output drive disc 1412 and thecoupler disc 1300). The coupler disc 1300 is also urged upward, with itsmovement limited by the outer flange 1370 of the coupler disc 1300 beingconstrained by the tool-side plate 1514.

Following attachment of the frame 1520 to the tool driver 1410, theoutput drive disc 1412 rotates (e.g., by actuating a motor coupled tothe output drive disc 1412) until its arcuate feature 1426 isrotationally aligned with the coupler disc arcuate feature 1312. Despitesome amount of frictional contact between the output drive disc 1412 andthe coupler disc 1300 that may tend to cause the discs 1412 and 1300 tomove together, the frictional features on the outer flange 1360 maysubstantially prevent the coupler disc 1300 from rotating along with(e.g., in tandem with) the output drive disc 1412 as the output drivedisc rotates. For example, frictional features (e.g., raised bumps 1360as described above with reference to FIG. 13B) that rub against thetool-side plate 1514 may substantially prevent the coupler disc 1300from rotating while the output drive disc 1412 rotates in an effort toachieve rotational alignment with the coupler disc 1300. For example, aprocessor may be coupled to the tool driver and configured to controlone or more output drive discs 1412 (simultaneously, individually insequence, pairwise, etc.) to rotate until they are rotationally alignedand engaged with their corresponding rotatable coupler discs 1300. Insome variations, rotational alignment may be achieved by driving theoutput drive discs 1412 until each has rotated at least a predeterminedangle or number of rotations (e.g., 1, 1.5, 2, 2.5, 3, etc.) or apredetermined period of time. At some point during a threshold angle ornumber of rotations, each moving output drive disc 1412 will berotationally aligned with the substantially static rotatable couplerdisc 1300. Additionally or alternatively, rotational alignment may bedetermined, for example, with sensors (capacitive, etc.) located on oneor both of the interfacing sides of the output drive discs and therotatable coupler discs 1300 such that intimate, adjacent contactbetween the output drive discs and the rotatable coupler discs isdetected. As yet another example, rotational alignment may be detectedbased on reaction torque measured by one or more sensors in the tooldriver when a output drive disc 1412 becomes engaged with itscorresponding coupler disc 1300. Once this rotational alignment isachieved, the arcuate feature 1416 engages the coupler disc arcuatefeature 1312 (and drive pins of the output drive disc 1412 also engagethe drive features of the coupler disc 1300), at least in part becausethe output drive disc 1412 is biased against the coupler disc 1300.

In FIG. 15D, a surgical tool 1420 is being attached to the sterileadapter (e.g., the frame and/or the plate assembly) by moving along thesterile adapter in the direction shown by arrow E. The surgical tool1420 couples to the sterile adapter when all adapter engagement features1428 on the tool (e.g., a rib similar to ribs 26 a-26 d described abovewith reference to FIG. 9B) engage with all corresponding tool engagementfeatures 1515 on the plate assembly, as partially shown in FIG. 15E.

As shown in FIG. 15E, the output drive disc 1412 and coupler disc 1300are still engaged. Input drive discs 1422 on the surgical tool are notyet engaged with the coupler discs 1300 and thus tend to push couplerdiscs 1300 and the plate assembly downward due to non-engagement. Toprovide a counter force, the shifting plate assembly (including plates1512 and 1514) is biased upwards against the surgical tool 1420 by oneor more springs on the shifting plate assembly (e.g., spring 1136 asdescribed above with reference to FIGS. 11A and 11B), thereby causingthe coupler disc 1300 to be pressed against the tool drive-side plate1512 and creating upper clearance between the coupler disc 1300 and theinput drive disc 1422 of the tool. Furthermore, the springs on theshifting plate assembly encourage engagement of the plate assembly toone or more adapter engagement features 1428 on the tool, therebyhelping to prevent the surgical tool 1420 from falling off of thesterile adapter.

Following attachment of the surgical tool 1420 to the sterile adapter,the coupler discs 1300 may rotate (simultaneously or individually insequence, etc.) via rotation of the output drive discs 1412 in an effortto achieve rotational alignment with corresponding input drive discs1422 on the surgical tool. Rotational alignment between the couplerdiscs 1300 and the corresponding input drive discs 1422 may be broughtabout and/or detected, for example, in the same or similar manner asrotational alignment between the output drive discs 1412 and the couplerdiscs 1300 described above. Such rotational alignment is achieved whenall arcuate features 1426 on the tool input drive discs 1422 are alignedwith corresponding arcuate features 1352 on the coupler disc 1300 (anddrive pins 1424 on the input drive disc 1422 are aligned with drivefeatures 1354 on the coupler discs 1300). Before this stage, anyrotational misalignment between a coupler disc 1300 and a correspondinginput drive disc 1422 will tend to push coupler discs 1300 and the plateassembly downward. For example, as shown in FIG. 15F, the coupler disc1300′ depicted on the left is not yet rotationally aligned with itscorresponding input drive disc 1422, while the coupler disc 1300depicted on the right is rotationally aligned with its correspondinginput drive disc 1422.

When all coupling discs 1300 are rotationally aligned with correspondinginput drive discs 1422, then coupling discs 1300 become engaged with theoutput drive discs 1412 on the tool driver and engaged with the inputdrive discs 1422 on the surgical tool, as shown in the arrangement shownin FIG. 15G. Furthermore, the biasing springs on the plate assembly 1510push the plate assembly 1510 upwards against the tool. As a result, thecoupler disc 1300 is generally centered within the plate assembly 1510,where it has upper and lower clearance to rotate within the plateassembly freely (e.g., such that the friction bumps on the outer flangeof the coupler disc do not contact any surface). Accordingly, thecoupling discs 1300 are ready to communicate torque from the outputdrive discs 1412 to the input drive discs 1422, across the sterilebarrier which the sterile adapter is part of.

To decouple the surgical tool from the sterile adapter, a latch (e.g., alever mechanism or button) on the surgical tool may function to depressor push down the shifting plate assembly away from the surgical tool.When the shifting plate assembly is sufficiently depressed, the couplingdiscs 1300 become separated and disengage from the input drive discs1422 of the surgical tool, thereby allowing the surgical tool to beremoved from the sterile adapter. Furthermore, the sterile adapter framemay be delatched (e.g., disengaging a locking mechanism such as thelocking mechanism 630 described above with reference to FIG. 6A orlocking mechanism 630′ described above with reference to FIG. 6C) fromthe tool drive, then lifted to separate and disengage the coupling discs1300 from the output drive discs 1412 of the tool drive, therebyallowing the sterile adapter to be removed from the surgical tool.

Coupling and Decoupling Variations

In some variations, the sterile adapter may additionally oralternatively include a removable film to help orient the rotatablecouplers in the sterile adapter, such as when engaging the output drivediscs in the tool driver with the rotatable couplers in the sterileadapter. For example, the coupler discs on the sterile adapter may bepre-aligned with a removable film before and during attachment of theframe to the tool driver. For example, as shown in FIG. 17A, a sterileadapter 1700 may include a removable film 1702 on a tool-side of thesterile adapter that adheres to the coupler discs 1710 and keeps thecoupler disc drive features 1712 in a predetermined orientation. Beforeattaching the sterile adapter 1700 to the tool driver 1720, the outputdrive discs 1722 may be rotated (e.g., by actuating the motors coupledto the output drive discs 1722) to a predetermined orientation. Forexample, the output drive discs 1722 may be rotated to be in-line with alongitudinal or axial direction along the tool as shown in FIG. 17B,and/or rotated to correspond to the predetermined orientation of thecoupler discs 1710. Upon attaching the sterile barrier 1700 to the tooldriver 1720, the removable film 1702 may keep the coupler discs 1712substantially stationary such that the output drive discs 1722 may berotated to seek rotational alignment with the coupler discs 1712. Oncerotational alignment is achieved, the removable film 1702 may be removed(e.g., peeled off, rubbed off, scratched off, etc.) as shown in FIG.17C. The removable film 1702 may include, for example, polyurethane,polyethylene terephthalate (PET), and/or any suitable materialattachable with a pressure-sensitive adhesive or other suitableadhesive. In some variations, the removable film 1702 may also functionas protection for the sterile adapter, such as during transport orstorage.

In some variations, the coupling of a surgical tool to a sterile adaptermay involve selectively exposing the sterile adapter's rotatablecouplers for coupling and selectively covering them for decoupling fromthe surgical tool) due to a latch on or actuatable by the surgical tool.For example, in one variation as shown in FIG. 18A, a surgical tool 1730may include at least one lever 1732 that is actuatable (e.g., bypinching levers on both sides of the surgical tool 1730). As shown inFIG. 18D, when the levers 1732 are depressed inwards, lever arms 1734are configured to push down and displace at least the sterile adapter'srotatable couplers 1710. Accordingly, when the surgical tool 1730 issliding over the sterile adapter as shown in FIG. 18B, the levers 1732may be depressed inwards to substantially prevent engagement between therotatable couplers 1710 and the input drives of the tool driver (notshown). As shown in FIG. 18C, when the surgical tool 1730 issufficiently seated in the sterile adapter, the levers 1732 may bereleased, thereby moving the lever arms 1734 away from the sterileadapter 1700 and allowing the sterile adapter's rotatable couplers 1710(biased upwards as described above, such as with springs or magnets) tomove upwards and engage with the input drives of the surgical tool.Furthermore, each levers 1732 may include at least one lever foot 1736configured to rest in a lateral cutout 1706 (shown in FIG. 18B) in thesterile adapter 1700 in order to continue permitting the rotatablecouplers 1710 to be biased upwards, thereby maintaining tool input driveengagement with the sterile adapter's rotatable couplers 1710.

The surgical tool 1730 may be decoupled from the sterile adapter 1700 byreversing the coupling process described above. For example, as shown inFIG. 19A, the levers 1732 may be depressed inwards, thereby moving thelever arms 1734 (not pictured) to push down and displace the sterileadapter's rotatable couplers 1710 (not pictured). The displacement ofthe rotatable couplers 1710 causes the input drives of the tool 1730 todisengage from the sterile adapter, which permits the surgical tool 1730to be withdrawn as shown in FIG. 19B.

FIGS. 20A and 20B illustrate another variation for selectively exposingand hiding the sterile adapter's rotatable couplers due to a latch on oractuatable by the surgical tool. As shown in FIG. 20A, a sterile adapter2000 may include a shifting plate 2022 that is spring-loaded to bebiased upward toward the surgical tool 2030. The shifting plate 2022 maybe restrained against the spring load by a locking lever 2020 in anengaged position such that the shifting plate 2022 restrains therotatable coupler 2010 in a retracted position, which is alsospring-loaded and biased upward toward the surgical tool 2030. While thelever is in the position shown in FIG. 20A and the rotatable coupler2010 is retracted or hidden, the rotatable coupler 2010 is not able toengage with the input drive disc 2032 of the surgical tool 2030. Thesurgical tool may approach being seated in the sterile adapter 200(e.g., moved in the direction of the arrow F) until it encounterslocking lever 2020. Locking lever 2020 pivots to a disengaged positionas shown in FIG. 20B, thereby releasing the biased shifting plate 2022.The shifting plate 2022 is biased to move upward toward the surgicaltool, thereby allowing the rotatable coupler 2010 to also extend upwardtoward the surgical tool 2030 and engage the input drive disc 2032. Uponengagement of the rotatable coupler 2010 and the input drive disc 2032,the rotatable coupler 2010 may be driven and communicate torque to thesurgical tool 2030.

The surgical tool 2030 may be decoupled from the sterile adapter 2000 byreversing the coupling process described above. For example, a latchmechanism (not shown) may push down on a shifting plate member 2024until the locking lever 2020 is restored its engaged position shown inFIG. 20A, whereupon the locking lever 2020 restrains the shifting plate2022 and again retracts the rotatable coupler 2010. Upon retraction ofthe rotatable coupler 2010, the rotatable coupler 2010 is decoupled fromthe surgical tool 2030 so that the surgical tool 2030 may be removed.

Axially Shifting Plate Assembly Variation

In another variation as shown in FIGS. 21A-21C, a sterile adapter 2100may include a plate 2110 having a tool-side face configured to couple toa surgical tool 2150. The plate 2110 may include one or more alignmentfeatures for facilitating the coupling and engagement of the surgicaltool 2150. For example, as shown in FIG. 21A, the plate 2110 may includea female guide 2114 (e.g., one or more longitudinal rail pairs)configured to engage a male guide 2156 (FIG. 21B) (e.g., alongitudinally-directed projection) or other guiding feature on thesurgical tool 2150 to help center the surgical tool 2150 as it is seatedonto the sterile adapter 2100 as shown in FIG. 21C. As shown in FIG. 2B,a leading end of the male guide 2156 may be tapered to facilitate agradual centering or alignment with the female guide 2114 as thesurgical tool 2150 is attached to the sterile adapter 2100. Additionallyor alternatively, the plate 2110 may include a male feature thatprojects outwardly and the surgical tool may include a female guideconfigured to receive the male guide on the plate 2110. As anotherexample, as shown in FIG. 21A, the plate 2110 may include one or moremagnets 2112 on the tool-side face that is configured to magneticallyattract a magnetic component 2156 on the surgical tool 2150. Forexample, the plate may include a magnet 2112 generally along acenterline of the plate 2110 projection 2156 (FIG. 21B) that isconfigured to attract and thereby center a centrally-placed magneticcomponent on the surgical tool 2150 (e.g., the male guide 2156, whichmay include a ferromagnetic material) or other magnet component coupledto a centerline of the surgical tool 2150.

As shown in FIGS. 22A and 22B, magnetic and/or ferromagnetic materialcomponents may further be included in one or more output drives 2142 ofthe tool driver 2140, in one or more rotatable couplers 2130 in the tooldriver 2100, and/or one or more input drives 2152 in the surgical tool2150, including a suitable combination of magnetically attractive and/ormagnetically repulsive materials or components, in order to encourageself-alignment of mating components. For example, at least one outputdrive 2142 on the tool driver 2140 may include one or more magnets 2144,and at least one corresponding coupler 2130 in the sterile adapter 2100may include one or more magnets 2132. The magnet 2144 may attract themagnet 2132, thereby urging self-alignment and engagement of the outputdrive 2142 and the coupler 2130. As another example, at least one inputdrive 2152 on the surgical tool 2150 may include one or more magnets2153. Magnet 2132 on the sterile adapter coupler may attract the magnet2153 on the surgical tool input drive, thereby similarly urgingself-alignment and engagement of the coupler 2130 and the input drive2152.

In some variations, as shown in FIG. 23A, the sterile adapter 2100 mayinclude a shifting plate 2120 configured to shift axially in-plane(e.g., in a longitudinal direction along the direction of the tool shaftof the surgical tool), where the shifting plate 2120 is configured toselectively permit extension and retraction of the rotatable couplers2130 in the sterile adapter. For example, the shifting plate 2120 mayinclude slots that are configured to enable translation of the shiftingplate 2120 around the output drives 2120. Furthermore, each slot mayhave a raised border that is engaged with a corresponding output drive2130, where the raised border may be ramped or sloped from one end ofthe slot to the other for selectively permitting extension andretraction of the couplers 2130 in the sterile adapter. For example, ina “couplers retracted” position shown in FIG. 23A, the couplers 2130 maybe engaged with a highest point of the raised slot border, which forcesthe couplers 2130 to withdraw toward the tool driver-side of the sterilebarrier (and away from the tool driver). For example, as shown in FIG.23A, the retracted couplers 2130 may be substantially flush with atool-side of the sterile adapter 2100. In a “couplers extended” positionshown in FIG. 23B, the couplers 2130 may be engaged with a lowest pointof the raised slot border, which permits the couplers 2130 (which may beurged outward due to spring-loading and/or magnets, etc.) to extendoutward beyond the tool-side of the sterile adapter.

Similar to at least some of the above-described variations, the shiftingof the plate 2120 between the “couplers retracted” and “couplersextended” positions may be triggered by engagement and/or disengagementof the surgical tool 2150 from the sterile adapter 2100. For example, asshown in FIG. 23C, the surgical tool 2150 may include a tool plate 2160configured to shift up and down on a sterile adapter-facing side of thetool. The tool plate 2160 may include a slot around each input drive2152 so as to enable shifting of the tool plate 2160 without interferingwith the input drives 2152. The shifting of the tool plate 2160 may becontrolled, for example, via a connection within the tool to the movableside grips 2162, which may be configured to be held and actuated by auser. For example, the side grips 2162 may slide within a groove in thesurgical tool 2150, and may include frictional features such as atextured surface (e.g., ribs or fingerhold contours) and/or a highfriction material (e.g., silicone). Additionally or alternatively, theshifting of the tool plate 2160 may be controlled by a latch, lever,button, turn wheel, or any suitable mechanism.

The tool plate 2160 may further include shifting plate actuatingfeatures 2163 (e.g., a cutout in longitudinal ribs). Furthermore, asshown in FIG. 23B, the shifting plate 2120 may include one or moreextensions 2122 that extend through openings of the sterile adapterplate 2100 to a tool-side of the sterile adapter plate 2100. The processof attaching the surgical tool 2150 to the sterile adapter 2100 maycause the tool plate 2160 to shift downward. When the tool plate 2160 isshifted downward from the position shown in FIG. 23C, the shifting plateactuating features 2163 may engage the extensions 2122 and cause theshifting plate 2120 to transition from the “couplers retracted” positionshown in FIGS. 23A and 23B to the “couplers extended” position shown inFIGS. 24A and 24B. In some variations, the tool plate 2160 may includeone or more springs 2164 or other suitable biasing features (e.g., leafspring) that are configured to bias the tool 2150 toward engagement withthe sterile adapter. When the coupler discs 2130 are extended in thismanner, they may be configured to rotationally align with and engage theinput drives 2152 of the surgical drive.

To decouple the surgical tool 2150 from the sterile adapter 2100, areverse process may be followed. For example, the side grips 2162 of thetool 2150 may be actuated upward, thereby causing the tool plate 2160 toshift upwards. When the tool plate 2160 is shifted upward from theposition shown in FIG. 24C, the shifting plate actuating features 2163may engage the extensions 2122 and overcome the biasing force providedby springs 2164 in order to cause the shifting plate 2120 to transitionfrom the “couplers extended” positions shown in FIGSS. 24A and 2B to the“couplers retracted” position shown in FIGS. 23A and 23B. When thecoupler discs 2130 are retracted in this manner, they are disengagedfrom the input drives 2152 of the surgical tool, thereby permittingdecoupling of the surgical tool 2150 from the sterile adapter 2100.

The foregoing description, for purposes of explanation, used specificnomenclature to provide a thorough understanding of the invention.However, it will be apparent to one skilled in the art that specificdetails are not required in order to practice the invention. Thus, theforegoing descriptions of specific embodiments of the invention arepresented for purposes of illustration and description. They are notintended to be exhaustive or to limit the invention to the precise formsdisclosed; obviously, many modifications and variations are possible inview of the above teachings. The embodiments were chosen and describedin order to best explain the principles of the invention and itspractical applications, and they thereby enable others skilled in theart to best utilize the invention and various embodiments with variousmodifications as are suited to the particular use contemplated. It isintended that the following claims and their equivalents define thescope of the invention.

1. A sterile barrier for use in a robotic surgical system, the sterilebarrier comprising: a sterile adapter comprising: a frame configured tobe interposed between a tool driver and a surgical tool, wherein theframe has a frame perimeter; and at least one peripheral projectionextending laterally around at least a portion of the frame perimeter;and a sterile drape coupled to the projection.
 2. The sterile barrier ofclaim 1, wherein the frame includes a first material and the peripheralprojection includes a second material different from the first material.3. The sterile barrier of claim 2, wherein the first material is morerigid than the second material.
 4. The sterile barrier of claim 2,wherein the second material comprises a flexible elastomeric material.5. The sterile barrier of claim 1, wherein the peripheral projectioncomprises an outer flange extending laterally around the frameperimeter.
 6. The sterile barrier of claim 5, wherein the peripheralprojection extends laterally between about 0.5 cm and 1.0 cm.
 7. Thesterile barrier of claim 1, wherein the peripheral projection isintegrally formed with the frame.
 8. The sterile barrier of claim 7,wherein the peripheral projection is co-injection molded with the frame.9. The sterile barrier of claim 1, wherein the sterile drape isthermally bonded to the peripheral projection.
 10. The sterile barrierof claim 1, further comprising a second peripheral projection layeredwith the first peripheral projection.
 11. The sterile barrier of claim1, wherein the sterile drape is disposed between the first and secondperipheral projections.
 12. A method for making a sterile barrier foruse in a robotic surgical system, the method comprising: co-injectionmolding a frame and at least one peripheral projection, wherein theframe has a frame perimeter and the peripheral projection extendslaterally around at least a portion of the frame perimeter; and couplinga sterile drape to the peripheral projection.
 13. The method of claim12, wherein the peripheral projection extends laterally around the frameperimeter.
 14. The method of claim 12, wherein co-injection molding theframe and the least one peripheral projection comprises introducing afirst material into a first portion of a mold corresponding to the frameand introducing a second material into a second portion of the moldcorresponding to the peripheral projection, wherein the first and secondmaterials are different.
 15. The method of claim 14, wherein the firstmaterial is more rigid than the second material.
 16. The method of claim12, wherein coupling the sterile drape to the projection comprisesthermally bonding the sterile drape to the peripheral projection. 17.The method of claim 12, wherein co-injection molding the frame and theat least one peripheral projection further comprises co-injectingmolding a second peripheral projection that extends laterally around atleast a portion of the frame perimeter.
 18. The method of claim 17,wherein the second peripheral projection is layered with the firstperipheral projection.
 19. The method of claim 18, wherein coupling thesterile drape comprises arranging at least a portion of the steriledrape between the first and second peripheral projections.